MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that there was a crack in the right cylinder connecting tube.The ipp was explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is ((b)(4).Correction to field g2: report source.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.The pump did not pass activation tests.No leaks were identified.The pump passes the microscope test.The cylinders were microscopically inspected, and leak tested.Leaks were identified.The microscope test revealed that the first cylinder had a hole at corner of a fold in the distal end of the cylinder and had a hole and tool marks in the outer tube from sharp instrument in the proximal end of the cylinder.The second cylinder had a hole and tool damage in the proximal end of the cylinder from sharp instrument.Both cylinders had wear at fold in the proximal end and distal end of the cylinder.Based on the information available and analysis results, the leak identified in the first cylinder confirmed the reported clinical observation of a crack in the right cylinder's connecting tube.Additionally, the pump not passing the activation test, corroborated to the reported issue of device not working properly.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that there was a crack in the right cylinder connecting tube.Both cylinder and pump were removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.No patient complications reported.

• Brand Name: AMS 700 LGX
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22035197
• Report Number: 2124215-2025-31617
• Device Sequence Number: 15835266
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)211121(10)157587019
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/03/2021
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 0145441001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN 72404161 LOT 1100627060; UPN 72404310 LOT# 161840003 - PUMP MS; UPN 72404310 LOT# 161840003 - PUMP MS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male